Study to Evaluate Efficacy of Aflibercept in Neovascular Age-related Macular Degeneration Patients Non Responders to Anti-Vascular Endothelial Growth Factor (MACBETH)

November 21, 2018 updated by: Barcelona Macula Foundation

Phase IV Study to Evaluate the Efficacy of Aflibercept in Subjects With Neovascular Age-related Macular Degeneration (wAMD), Without Optimal Response to Repeated Monthly Intravitreal Injections of Anti Vascular Endothelial Growth Factor (Anti VEGF-A) Therapy.

Patients with neovascular age-related macular degeneration who do not respond to usual treatment with conventional medications may respond to a new drug of the same class which is designed to block a larger fraction of proangiogenic factors.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08022
        • Barcelona Macula Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed Informed Consent
  • Men and women ≥ 50 years of age.
  • Any choroidal neovascular membranes (CNVM) lesion (occult, minimally classic or classic) secondary to age-related macular degeneration
  • Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of: 20/32 to 20/320 (letter score of 73 to 25) in the study eye.
  • Able to return for ALL clinic visits and complete all study-related procedures.
  • Absence of other ocular diseases that could affect visual acuity.
  • Patients without optimal response to ranibizumab or bevacizumab defined as:

    • Patient with significant persistent or recurrent fluid (intraretinal or subretinal) on OCT or any leakage on fluorescein angiography despite at least 4 injections within last 6 months, being the last OCT with presence of fluid within the 6 weeks after last treatment with ranibizumab or bevacizumab.
    • Patient with significant persistent or recurrent fluid (intraretinal or subretinal) on OCT or any leakage on fluorescein angiography despite three monthly treatment with ranibizumab or bevacizumab.

Exclusion Criteria:

  • No scar, fibrosis, or atrophy involving the center of the fovea
  • No retina pigment epithelium (RPE) rip/tear involving the central fovea
  • Participation in another simultaneous interventional clinical trial
  • Prior treatment with anti-VEGF or steroids therapy in the study eye within 28 days of baseline
  • Prior treatment with photodynamic therapy (PDT)
  • Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
  • Active intraocular inflammation in the study eye
  • History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
  • Unable to undergo fluorescein angiography or fundus photography because of uncontrolled allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.5mg AFLIBERCEPT injection
Patients will receive intravitreal injection of aflibercept 0.5mg at baseline, week 4,8,16,24 and 32. Optionally, if intra or subretinal fluid persists at week 12, patients will receive an additional injection.
0.5mg aflibercept intravitreal injection will be performed every 4 weeks from baseline to week 8 (3 doses) and every 8 weeks until week 32.
Other Names:
  • EYLEA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with no fluid on Optical Coherence Tomography (OCT) after loading dose of aflibercept
Time Frame: Week 12
At week 12 an OCT will be performed to evaluate the changes in intra or subretinal fluid and to determine the percentage of patients with no fluid after 3 doses of aflibercept injected on baseline visit, week 4 and week 8.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in best corrected visual acuity (BCVA)after loading dose
Time Frame: week 12
week 12
Changes in OCT central foveal thickness after loading dose
Time Frame: week 12
week 12
Anatomic and Visual Acuity outcomes maintained during (every 8 weeks) treatment.
Time Frame: week 40
week 40
Determine the time to resolution of any intra/sub retinal fluid on OCT
Time Frame: week 4,8,12,24,32,40
week 4,8,12,24,32,40
Describe safety of this cohort of patients
Time Frame: baseline, week 4, 8, 12, 24, 32 and 40
Describe the safety of aflibercept in study patients by determining ocular and non ocular adverse events classified according to type, frequency and severity during 40 weeks
baseline, week 4, 8, 12, 24, 32 and 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jordi Mones, MD PhD, Barcelona Macula Foundation
  • Principal Investigator: Carlos Juan Donate, MD, Hospital San Carlos, Madrid
  • Principal Investigator: Marta Suárez de Figueroa, MD, Hosipital Universitario Ramon y Cajal
  • Principal Investigator: Jose Luis Olea, MD, Hospital Son Espases
  • Principal Investigator: Francisco Cabrera, MD, Hospital Universitario Insular de Canarias
  • Principal Investigator: Laura Sarasols, MD, Hospital Universitari General de catalunya
  • Principal Investigator: Javier Araiz, MD, Instituto Clínico Quirúrgico de Oftalmología de Bilbao
  • Principal Investigator: Jose Maria Ruiz-Moreno, MD, Hospital Universitario de Albacete
  • Principal Investigator: Ignasi Jürgens, MD PhD, Institut Catala de Retina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Actual)

November 23, 2018

Last Update Submitted That Met QC Criteria

November 21, 2018

Last Verified

July 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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